IPS-INTEGRATED

IPS-Integrated Project Services, LLC, a leading provider of engineering, procurement, construction management, and validation (EPCMV) services, congratulates WuXi Biologics Ireland Limited (WuXi Biologics) for receiving a Facility of the Year Award (FOYA) from The International Society for Pharmaceutical Engineering (ISPE) in the Operations category for their Large-Scale Manufacturing Facility in Mullagharlin, Dundalk, Ireland. The IPS team of experts provided a range of services for the project, including process design, engineering, architecture, construction management, and validation support.

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The ISPE Facility of the Year Awards (FOYA) program recognizes state-of-the-art pharmaceutical manufacturing facilities utilizing innovative design and construction strategies to produce high-quality, safe, cost-effective medicines. WuXi Biologics was recognized for its cutting-edge biologics manufacturing facility in Dundalk, Ireland. The FOYA judges found this project “an inspiring landmark that proves that facilities can be developed on a highly accelerated schedule, using innovative solutions while complying with regulatory requirements, overcoming unknown barriers, cooperation with the community, and upholding project success and product safety.”

Brendan McGrath, Vice President and Head of WuXi Biologics Ireland site, commented, "This recognition by ISPE is a testament to our team's dedication and relentless pursuit of excellence. We are also extremely grateful for the exceptional work of IPS, our facility designer, whose expertise significantly contributed to our achievement. This award signifies success not only for our team but also for our clients, partners, and local community. Ultimately, it's a victory for the patients who rely on the life-saving biologics manufactured at our Ireland site."

The WuXi Biologics facility is one of the world’s largest contract manufacturing single-use bioreactor sites. However, the facility’s real achievement is its unprecedented flexibility in cell culture-based manufacturing regardless of batch size by “scaling out” with 12 ABEC 4,000-liter capacity bioreactors. The facility’s flexible array of highly-configurable systems and overall capability to adapt to almost any perfusion, fed-batch, concentrated fed-batch, and intensified fed-batch techniques reduce client risk. This capability, combined with innovations in automation, single-use materials, and transition time, transforms the WuXi Biologics facility into a game changer for the production of emerging antibody-based therapies on a global impact.

The project was the first in Ireland to be delivered using an innovative design-assist model. IPS developed design packages to 60% detailed design; the remaining 40% was completed with engagement from the construction team, including subcontractors. This collaborative approach improved constructability, reduced time/cost, and significantly reduced rework. The single-use technology allows for a capacity of 48,000L, making it the largest single-use bioreactor in Ireland and possibly all of Europe.

The fast-track project was completed with over 6.2 million work hours in 26 months, with an average of 2,200 employed at peak. A total of 7,610 personnel were inducted on-site. Throughout construction in 2019 and 2020, more than 75 archaeologists were empowered to dig at sites spread across the campus. The artifacts found on the site depict common and extraordinary life spread across thousands of years—everything from fine sewing needles carved from bone to medieval spearheads and a cache of shiny 10th-century coins. WuXi Biologics maintained the schedule during their archaeological preservation and COVID challenges.

“IPS has been a partner to WuXi Biologics since its early days, and it is great to see it win the prestigious Facility of the Year Award. I still remember the early days of this project conception and when WuXi Biologics procured the massive site in Dundalk. Seeing the fantastic conclusion of all the efforts that followed is truly memorable. We are honored to have been part of this state-of-the-art facility which truly represents innovation, cutting-edge technology, and excellence. Congratulations to WuXi Biologics on this incredible achievement,“ said Dave Goswami, PE, IPS Chairman and Chief Executive Officer.

Cell-based therapeutics are transforming modern medicine, and WuXi Biologics’ facility is highly flexible and adaptable, ensuring the facility will have the capacity to produce a variety of new cellular therapies for years to come.

About IPS

IPS, a Berkshire Hathaway Company, is a global leader in developing innovative business solutions for the biotechnology and pharmaceutical industries. Through operational expertise and industry-leading knowledge, skill, and passion, IPS provides consultancy services, architecture, engineering, project controls, construction management, and compliance services that allow clients to develop and manufacture life-impacting products. Its newest acquisition, Linesight, specializes in cost, schedule, risk, program, and project management services in various market sectors, including data centers, life sciences, and high-tech industrial. With the addition of Linesight, IPS has over 3,000 professionals in over 45 offices across 17 countries in the Americas, Europe, Asia Pacific, Southeast Asia, Australia, and the Middle East. For further information, please visit www.ipsdb.com.

About WuXi

WuXi Biologics (stock code: 2269.HK) is a leading global Contract Research, Development and Manufacturing Organization (CRDMO) offering end-to-end solutions that enable partners to discover, develop and manufacture biologics – from concept to commercialization – for the benefit of patients worldwide.

With over 12,000 skilled employees in China, the United States, Ireland, Germany and Singapore, WuXi Biologics leverages its technologies and expertise to provide customers with efficient and cost-effective biologics discovery, development and manufacturing solutions. As of December 31, 2022, WuXi Biologics is supporting 588 integrated client projects, including 17 in commercial manufacturing.

WuXi Biologics views Environmental, Social, and Governance (ESG) responsibilities as an integral component of our ethos and business strategy, and we aim to become an ESG leader in the biologics CRDMO sector. Our facilities use next-generation biomanufacturing technologies and clean-energy sources. We have also established an ESG committee led by our CEO to steer the comprehensive ESG strategy and its implementation, enhancing our commitment to sustainability. For more information about WuXi Biologics, please visit www.wuxibiologics.com.

About the ISPE Facility of the Year Awards Program

Established in 2005, The Facility of the Year Awards (FOYA) recognize state-of-the-art projects utilizing new, innovative technologies to improve the quality of products, reduce the cost of producing high-quality medicines, and demonstrate advances in project delivery. The FOYA program provides a platform for the pharmaceutical science and manufacturing industry to showcase its accomplishments in facility design, construction, and operation, while sharing the development of new applications of technology and cutting-edge approaches. Visit ISPE.org/FOYA for more information.

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